STAT

SEPTEMBER 19, 2024

GLP-1 based drugs are transforming the treatment of obesity and opening up new avenues for addressing heart disease , addiction , and even Alzheimer’s. Now, three scientists who played key roles in their invention have won a prestigious Lasker Award for biomedical research.  Announced on Thursday in New York, the Lasker-DeBakey Clinical Medical Research Award will be shared by Svetlana Mojsov and Joel Habener , who identified and characterized the GLP-1 hormone in the 1980s whil

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Pharmaceutical Companies Pharmaceutical Companies Hospitals 145

Drug Topics

SEPTEMBER 19, 2024

Johnny Garcia, Senior Director of Policy at the Pharmaceutical Care Management Association, discussed ongoing issues within the pharmaceutical supply chain and his organization’s role within it.

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STAT

SEPTEMBER 19, 2024

NEW YORK — Nearly two decades ago, European regulators pulled an obesity drug called rimonabant off the market due to concerns it was tied to suicidal ideation. Now, a small handful of companies are developing drugs that use a similar approach to the discarded treatment, which involves inhibiting type 1 cannabinoid receptors, or CB1 receptors.

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Fierce Healthcare

SEPTEMBER 19, 2024

Three months ago, startup Hippocratic AI released its first commercial product, a generative AI-based, task-specific healthcare agent. | Nvidia's venture capital arm, NVentures, along with Greycroft and Lee Shapiro of 7Wire Ventures, backed a $17 million investment in Hippocratic AI to fuel its product development of generative AI "agents.

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Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

STAT

SEPTEMBER 19, 2024

Amid layoffs and a disintegrating share price, former investor darling Ginkgo Bioworks is trying out a new tack to find customers. The biotech this week announced a new artificial intelligence model for use in biological research, as well as a data service academic researchers and companies can use to develop their own models. The announcement comes as a growing number of biotechs, big tech companies, and academics apply neural networks and machine learning to biology, promising that the same ba

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Drug Topics

SEPTEMBER 19, 2024

Compounded with lifestyle interventions, researchers compared liraglutide with a placebo to measure its efficacy amongst children under 12 years old.

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Compounding 112

Fierce Healthcare

SEPTEMBER 19, 2024

Major Indiana managed care organizations and health systems are blamed for defrauding the state Medicaid system by tens, if not hundreds, of millions of dollars, says a newly unsealed whistleblower | A newly unsealed lawsuit alleges major health insurers and health systems defrauded Indiana Medicaid by hundreds of millions of dollars, with the government office likely influenced by corporate lobbying.

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Fierce Pharma

SEPTEMBER 19, 2024

From truckloads of torn documents to avian incursions in the production plant, Granules India’s recent manufacturing reprimand from the FDA is alarming no matter which way you look at it. | Earlier this month, Granules was slapped with a Form 483 following an inspection of its Telangana facility in India that ran from Aug. 26 to Sept. 6. The FDA’s report cites six observations around poor quality control procedures, subpar cleaning, cross-contamination risks and more.

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Documentation FDA 120

Drug Topics

SEPTEMBER 19, 2024

Following the Federal Trade Commission’s interim report on PBMs, legislators are galvanized to make change happen.

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Fierce Healthcare

SEPTEMBER 19, 2024

The Senate Committee on Health, Education, Labor and Pensions voted unanimously Thursday morning to bring civil enforcement and a criminal contempt charge against Steward Health CEO Ralph de la Tor | Ralph de la Torre, M.D., invoked the Fifth Amendment in his refusal to appear before Congress. Sens. Sanders and Cassidy said that he must invoke that right in person and in response to specific questions during testimony.

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Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

FDA

STAT

SEPTEMBER 19, 2024

Amid ongoing concern over the quality of medicines made in India, a major supplier of generic medicines was seen removing three truckloads of “scrap materials” from a facility that was being inspected last month by the Food and Drug Administration. Specifically, a “large number of torn pieces” of documents that should have been kept to verify manufacturing and testing practices were found in the trucks, as well as in a scrap bag at a site run by Granules in Telangana,

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Documentation FDA Generic Medicine 109

Fierce Pharma

SEPTEMBER 19, 2024

A study from The BMJ indicates that the newest class of migraine drugs—which includes Pfizer’s Nurtec, AbbVie’s Ubrelvy and Eli Lilly’s Reyvow—is less effective in the acute treatment of migra | A study from The BMJ indicates that the newest class of migraine drugs—which includes Pfizer’s Nurtec, AbbVie’s Ubrelvy and Eli Lilly’s Reyvow—is less effective in the acute treatment of migraines than a previous class of medicines.

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STAT

SEPTEMBER 19, 2024

A group of lawmakers wants the U.S. Patent & Trademark Office and drug companies to change their approach toward handling mistakes in disclosing patent terms, because the errors can be exploited in ways that thwart competition and, ultimately, raise the cost of medicines. The problem cited by the lawmakers concerns the way that administrative delays are handled at the PTO.

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Pharmaceutical Companies Pharmaceutical Companies 111

Pharmacy Times

SEPTEMBER 19, 2024

Results displayed a non-inferior immune response of the co-administered vaccines, compared to administration in individual visits.

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Vaccines Immunization 113

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STAT

SEPTEMBER 19, 2024

Are generalist investors good or bad for biotech? How did Elaine and Adam’s trip to New York go? And how long has George Church owned that brown corduroy blazer? We cover all that and more on the latest episode of “The Readout Loud.” Mizuho analyst Jared Holz joins us to discuss what the Federal Reserve’s long-awaited decision to lower interest rates means for biotech stocks and startups.

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pharmaphorum

SEPTEMBER 19, 2024

Explore how the pharmaceutical industry is ensuring supply chain resilience to maintain consistency despite global events. Learn more about strategies and practices implemented to address challenges and ensure reliable delivery of pharmaceutical products.

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STAT

SEPTEMBER 19, 2024

Rise and shine, everyone, another busy day is on the way. However, this is shaping up as a beautiful day as well, despite forecasts suggesting a cloud or two will later hover about. Right now, the skies are tranquil, birds are chirping, and the official mascots are hunting for snacks on the Pharmalot campus. This calls for celebration with a cup of stimulation, and we are reaching for maple bourbon, a reliable stand-by.

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Drug Topics

SEPTEMBER 19, 2024

Roche announced positive topline results from the phase 3 CENTERSTONE study that evaluated the efficacy of baloxavir marboxil for the reduction of direct flu transmission.

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SEPTEMBER 19, 2024

This is the online edition of Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up  here  to get it delivered to their inbox. I’ve been in New York City all week attending the Cantor Global Healthcare Conference and meeting with investor sources. Big thanks to Cantor hosts Josh Schimmer and Eric Schmidt for the invite.

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pharmaphorum

SEPTEMBER 19, 2024

Neuralink gets FDA breakthrough status for an implantable chip called Blindsight that promises to restore eyesight to the blind

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FDA 103

STAT

SEPTEMBER 19, 2024

Serial biotech founder George Church has a new startup, and this time, he has skin in the game, quite literally.  Church, the enigmatic founder behind companies including eGenesis , Editas Medicine, and Colossal Biosciences , donated some of his own skin cells for use at his new startup GC Therapeutics. (And yes, the letters in the company’s name stand for “George Church.

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Immunization 98

pharmaphorum

SEPTEMBER 19, 2024

FDA turns down Vanda Pharma's tradipitant for gastroparesis, prompting a furious response from the company

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FDA 110

STAT

SEPTEMBER 19, 2024

A Senate committee on Thursday approved referring Steward Health Care chief executive Ralph de la Torre for civil and criminal charges over his refusal to testify about the hospital chain’s financial crisis. The Senate Health, Education, Labor, and Pensions Committee voted 20 to zero, with only Kentucky Senator Rand Paul abstaining, on both resolutions to hold de la Torre in contempt of Congress after  he skipped appearing at a hearing last week  despite being subpoenaed.

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Hospitals 97

Fierce Pharma

SEPTEMBER 19, 2024

Gilead Sciences’ Kite Pharma will sell its stake in China’s Fosun Kite Biotechnology nearly eight years after forming the 50-50 cell-therapy-focused joint venture with Fosun Pharma. | Gilead Sciences’ Kite Pharma will sell its stake in China’s Fosun Kite Biotechnology nearly eight years after forming the cell therapy-focused joint venture with Fosun Pharma.

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STAT

SEPTEMBER 19, 2024

In June, a clinical trial showed that a twice-yearly injection was just as effective at preventing HIV as the daily oral medication. The trial  was so successful  that the Data Monitoring Committee instructed researchers to halt the study and immediately offer the injection to all study participants.  This is just the most recent development in longer-acting HIV medications, which have become a transformative force in the journey toward ending the HIV/AIDS crisis.

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Fierce Healthcare

SEPTEMBER 19, 2024

A health systems-backed tech company has reached a deal with Texas’ attorney general to settle allegations that a generative AI product used by “at least four major Texas hospitals” was less accura | Pieces Technologies agreed to more clearly disclose how it is describing its tools’ performance, and to provide more explicit disclosures to its hospital customers covering how the products are to be used and could potentially lead to patient harm.

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Hospitals 78

STAT

SEPTEMBER 19, 2024

Check out STAT’s exclusive breakthrough devices tracker.  The latest medical devices to receive breakthrough status from the Food and Drug Administration range across conditions, with several treating cardio and neurovascular conditions.  The FDA’s breakthrough devices program is designed to speed the path to market for novel, potentially lifesaving products.

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FDA 90

pharmaphorum

SEPTEMBER 19, 2024

Upstream Bio has become the latest biotech to chance its arm with a public listing in the US, seeking funds for its rival to respiratory drug Tezspire.

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STAT

SEPTEMBER 19, 2024

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences.  Sign up to get it  delivered in your inbox every Tuesday and Thursday. Talkspace offers therapy through Amazon now As virtual mental health company Talkspace aims to grow its business, it’s added a very large entry point to the top of its funnel.

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Pharmacy Times

SEPTEMBER 19, 2024

Tune into this episode of “Public Health Matters” to learn about the Unbiased Science podcast and how guest Jessica Steier, DrPH, PMP, aims to combat misinformation and disinformation, encouraging listeners to make evidence-based decisions.

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STAT

SEPTEMBER 19, 2024

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning. Some news from Washington from late yesterday: Lawmakers advanced legislation that would extend a program to aid the development of drugs for rare diseases in children.

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pharmaphorum

SEPTEMBER 19, 2024

Daiichi Sankyo's FLT3 inhibitor Vanflyta has been recommended for NHS use as a treatment for a specific form of acute myeloid leukaemia (AML) in England and Wales, the first countries in Europe to authorise use of the drug after a health technology assessment (HTA) review.

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Pharmacy Times

SEPTEMBER 19, 2024

Seroconversion was observed in 95.8% of participants but dropped to 75.6% at the 4-year follow-up.

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Vaccines 123

Fierce Healthcare

SEPTEMBER 19, 2024

2024 has been a year that has tested healthcare organizations' cyber resilience, and shone a spotlight on critical vulnerabilities. | Cybersecurity leaders at major health systems and leading health insurers say they are now keenly focused on building more a resilient healthcare ecosystem rather than just reacting to threats.

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Insurance 65